Genlabs Corporation — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm lacked an adequate quality unit (QU). For example, your QU failed to establish procedures describing QU roles, responsibilities, and authorities. Also, your QU’s oversight of your drug manufacturing operations were inadequate. For…

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). The water used to manufacture your drug products and clean your equipment comes from a system that you have not validated. You lack assurance that your water system consistently produces water suitable for…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You manufacture several over-the-counter (OTC) drug products, including Genlabs Strike Bac Antibacterial Hand Soap, under your own label, and First Street Antimicrobial Liquid Hand Soap, for your customer, (b)(4) . You manufacture these drug products using the same equipment that you use to manufacture numerous non-pharmaceutical industrial…

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary (21 CFR 211.165(a) and (b)). And your firm failed to establish the accuracy, sensitivity…